8-8 Dash™ 3000/4000/5000 2000966-386D
Monitoring ECG
CAUTION
FDA POSTMARKET SAFETY ALERT—The United States FDA
Center for Devices and Radiological Health issued a safety bulletin
October 14, 1998. This bulletin states “that minute ventilation rate-
adaptive implantable pacemakers can occasionally interact with
certain cardiac monitoring and diagnostic equipment, causing the
pacemakers to pace at their maximum programmed rate.”
The FDA further recommends precautions to take into consideration
for patients with these types of pacemakers. These precautions
include disabling the rate responsive mode and enabling an alternate
pace mode. For more information contact:
Office of Surveillance and Biometrics, CDRH, FDA
1350 Piccard Drive, Mail Stop HFZ-510
Rockville, MD 20850
U.S.A.
NOTE
ECG monitoring with patients on non-invasive transcutaneous pacemakers may
not be possible due to large amounts of energy produced by these devices.
Monitoring ECG with an external device (for example, a defibrillator) may be
needed. Remember that there are no ECG alarms at the monitor if you are
monitoring with an external devices.
Arrhythmia
The following safety statements apply when monitoring arrhythmia patients.
WARNING
VENTRICULAR ARRHYTHMIAS —Occasionally the arrhythmia
analysis program may incorrectly identify the presence or absence of
an arrhythmia. Therefore a physician must analyze the arrhythmia
information in conjunction with other clinical findings.
WARNING
SUSPENDED ANALYSIS—Certain conditions suspend arrhythmia
analysis. When suspended, arrhythmia conditions are not detected
and alarms associated with arrhythmias do not occur. The messages
which alert you to the conditions causing suspended arrhythmia
analysis are: Arr Off, Arrhy Suspend, and Leads Fail.
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